Part 2 – IRB Review Types

For human research, there are three types of IRB Review: exempted, expedited and full. A brief summary of each and their criteria is below. You will be notified of what type of review a research proposal is assigned by the IRB in writing.

 

Exempted review

Exempted research poses no risk to the subjects and requires very short review procedures to assure the ethics of the study. Continuing review is not needed. Research conducted in established or commonly accepted educational settings, involving normal educational practices is considered eligible for exemption. Also, interviews and surveys/questionnaires are eligible for exemption if the information gathered is poses no risk to the subject’s reputation or standing, or is recorded in a way that cannot be traced back to the subject. Secondary research of existing social science research can also be considered for exemption.

 

               Expedited review

Research is considered eligible for expedited review if it poses “minimal risk” to the subjects, which is defined as “the probability for discomfort or distress not being any greater than what the subject would reasonably experience in their daily lives.” If privacy is the primary risk involved and can be contained to be only a marginal possibility, it may also be considered for exemption. Exempted research can have continuing review.

 

               Full review

Research requires full review by an IRB and continuing review no less than once a year if it poses more than minimal risk to subjects and their privacy. Research approved this way may also involve vulnerable populations, which include prisoners, children and pregnant women. Continuing review are audits that must be completed at regular intervals that monitor study progress.

 

Research modifications

Study parameters that are modified after the study is approved must be submitted to the IRB for approval. They may require a full convening of the board to approve this.

 

Unanticipated risk or harms

Each institution is required to have procedures for reporting unanticipated events which can include incidents during studies involving harm befalling research subjects or complaints against the study. It is almost universally required to report these in writing to the IRB immediately after they occur.

 

Notes on Approval

Strictly by definition, the IRB is concerned with the ethics of the research submitted and not other organizational concerns. If an IRB approves research, if the institution has another level of approval (such as the approval of a dean or director), the institution may still deny the research for reasons such as budget or personnel. However, if the IRB denies research, it is considered unethical and the denial cannot be overruled by the institution.